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TREMFYA® (guselkumab)

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Treatment Effect of TREMFYA on Fatigue in Active Psoriatic Arthritis

Last Updated: 01/21/2025

Summary

The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
The effect of TREMFYA treatment on fatigue in adult patients with active psoriatic arthritis (PsA) was evaluated in 2 randomized, double-blind, placebo-controlled, multicenter, phase 3 studies (DISCOVER-1 and DISCOVER-2).¹^,²
- In DISCOVER-1, the least squares mean change from baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score at week 24 was 5.61 in the TREMFYA 100 mg every 8 weeks (q8w) group, 5.84 in the TREMFYA 100 mg every 4 weeks (q4w) group, and 2.21 in the placebo group (unadjusted P-values vs placebo: for both groups, P-value<0.001).
- In DISCOVER-2, the least squares mean change from baseline in the FACIT-Fatigue score at week 24 was 7.55 in the TREMFYA 100 mg q8w group, 7.11 in the TREMFYA 100 mg q4w group, and 3.56 in the placebo group (unadjusted P-values vs placebo: for both groups, P-value<0.001).
- In DISCOVER-1, the observed mean change from baseline in the FACIT-Fatigue score at week 52 was 7.5 in the TREMFYA q8w group, 6.9 in the TREMFYA q4w group, and 6.6 in the placebo to TREMFYA 100 mg q4w crossover group.
- In DISCOVER-2, the observed mean change from baseline in the FACIT-Fatigue score at week 52 was 8.9 in the TREMFYA q8w group, 7.7 in the TREMFYA q4w group, and 7.5 in the placebo to TREMFYA 100 mg q4w crossover group.
- A post hoc analysis of the DISCOVER-2 study observed that the least squares mean change from baseline in the FACIT-Fatigue score at week 100 was 10.33 in the TREMFYA 100 mg q8w group, 10.31 in the TREMFYA 100 mg q4w group, 10.04 in the pooled TREMFYA group, and 9.52 in the placebo to TREMFYA 100 mg q4w crossover group.
The COSMOS study was a phase 3b, randomized, placebo-controlled study that evaluated the use of TREMFYA in adult patients with active PsA who demonstrated inadequate response to 1-2 tumor necrosis factor inhibitors (TNFi).³
- The proportion of patients in the TREMFYA and placebo groups with a ≥4-point improvement from baseline in FACIT-Fatigue response at week 24 was 42.9% and 20.8%, respectively.

CLINICAL DATA

Phase 3

Rahman et al (2021)¹ evaluated the effect of treatment with TREMFYA on fatigue and the estimated proportion of FACIT-Fatigue response independent of the ≥20% improvement in the American College of Rheumatology Criteria (ACR20) response from the 2 randomized, double-blind, placebo-controlled, multicenter, phase 3 studies (DISCOVER-1 and DISCOVER-2).

Study Design/Methods

The study designs are presented in Figure: DISCOVER-1 Study Design and in Figure: DISCOVER-2 Study Design.

DISCOVER-1 Study Design⁴^,⁵

Abbreviations: CASPAR, Classification Criteria for Psoriatic Arthritis; CRP, C-reactive protein; csDMARD, conventional synthetic diseasemodifying antirheumatic drug; EE, early escape; NSAID, nonsteroidal anti-inflammatory drug; PsA, psoriatic arthritis; PsO, psoriasis; q4w, every 4 weeks; q8w, every 8 weeks; R, randomized; SC, subcutaneously; TNFi, tumor necrosis factor inhibitor.
^aPatients were eligible to initiate/increase background medications if there was <5% improvement from baseline in tender and swollen joint counts at week 16.

DISCOVER-2 Study Design⁶^,⁷

Abbreviations: CASPAR, Classification Criteria for Psoriatic Arthritis; cDMARD, conventional disease-modifying antirheumatic drug; CRP, C-reactive protein; EE, early escape; NSAID, nonsteroidal anti-inflammatory drug; PsA, psoriatic arthritis; PsO, psoriasis; q4w, every 4 weeks; q8w, every 8 weeks; R, randomized; SC, subcutaneously.
^aPatients were eligible to initiate/increase background medications if there was <5% improvement from baseline in tender and swollen joint counts at week 16.

In DISCOVER-1 and DISCOVER-2, the primary endpoint was the proportion of patients achieving an ACR20 response at week 24.⁴^,⁶
Fatigue was measured as a secondary endpoint using the FACIT-Fatigue score (range, 0-52; higher scores indicate less fatigue), a composite, patient-reported outcome.¹
- FACIT-Fatigue measures fatigue and its impact on daily activities and function during the previous week in patients with PsA.
- Treatment failure rules were applied to FACIT-Fatigue score analyses through week 24 and after week 24.
- Analysis of changes from baseline in FACIT-Fatigue scores was conducted using mixed-effect model–related measures, which included factors such as baseline use of nonbiologic disease-modifying antirheumatic drugs, prior use of TNFi (DISCOVER-1 only), and C-reactive protein (CRP) status (>2.0 or ≤2.0 mg/dL; DISCOVER-2 only).
- An increase in the FACIT-Fatigue score of at least 4 points was considered clinically meaningful improvement.
Mediation analysis used linear regression and logistics regression models with bootstrapping to determine the direct effect of TREMFYA on FACIT-Fatigue scores after adjusting for the indirect effect caused by the mediators, including pre-defined ACR20 response, achievement of minimal disease activity composite endpoint, or post hoc changes in serum CRP concentrations.

Results

Patient Characteristics

In DISCOVER-1, 381 patients were randomized to receive TREMFYA 100 mg q8w (n=127), TREMFYA 100 mg q4w (n=128), or placebo (n=126). Of these, 91% of patients completed treatment through 1 year.
In DISCOVER-2, 739 patients were randomized to receive TREMFYA 100 mg q8w (n=248), TREMFYA 100 mg q4w (n=245), or placebo (n=246). Of these, 93% of patients completed treatment through 1 year.
Baseline characteristics are summarized in Table: Summary of Patient Baseline Characteristics (DISCOVER-1 and DISCOVER-2).
At baseline, FACIT-Fatigue scores were consistent between groups and between studies.
In DISCOVER-2, at baseline, FACIT-Fatigue scores ≤43 (score lower than the published mean normative value of 43.5) in the TREMFYA 100 mg q8w, TREMFYA 100 mg q4w, and placebo→TREMFYA q4w groups were observed in 231 (93%), 217 (89%), and 233 (95%) patients, respectively.²

Summary of Patient Baseline Characteristics (DISCOVER-1 and DISCOVER-2)¹

	DISCOVER-1			DISCOVER-2
	TREMFYA		Placebo (n=126)	TREMFYA		Placebo (n=246)
	100 mg q8w (n=127)	100 mg q4w (n=128)	Placebo (n=126)	100 mg q8w (n=248)	100 mg q4w (n=245)	Placebo (n=246)
Age, years	49 (12)	47 (12)	49 (11)	45 (12)	46 (12)	46 (12)
Male gender, n (%)	68 (54)	66 (52)	61 (48)	129 (52)	142 (58)	117 (48)
BMI, mean, kg/m²	29.9 (6.4)	29.9 (5.5)	29.6 (5.7)	28.7 (6.3)	29.1 (5.9)	29.0 (6.4)
PsA disease duration, years	6.4 (5.9)	6.6 (6.3)	7.2 (7.6)	5·1 (5.5)	5.5 (5.9)	5·8 (5.6)
Components of ACR20 and MDA
Number of swollen joints (0-66)	10.9 (9.3)	8.6 (5.8)	10.1 (7.1)	11.7 (6.8)	12.9 (7.8)	12.3 (6.9)
Number of tender joints (0-68)	20.2 (14.5)	17.7 (13.1)	19.8 (14.4)	19.8 (11.9)	22.4 (13.5)	21.6 (13.1)
CRP, median (IQR), mg/dL	0.7 (0.4-1.9)	0.6 (0.3-1.3)	0.8 (0.3-1.5)	1.3 (0.7-2.5)	1.2 (0.6-2.3)	1.2 (0.5-2.6)
FACIT-Fatigue (0-52)	29.5 (11.3)	31.4 (10.1)	30.2 (9.9)	29.3 (9.9)	30.8 (9.6)	29.1 (9.5)
Data are mean (SD) unless otherwise stated. Abbreviations: ACR20, ≥20% improvement in American College of Rheumatology criteria; BMI, body mass index; CRP, C-reactive protein; FACIT, Functional Assessment of Chronic Illness Therapy; IQR, interquartile range; MDA, minimal disease activity; PsA, psoriatic arthritis; q4w, every 4 weeks; q8w, every 8 weeks; SD, standard deviation.

Efficacy

In DISCOVER-1 and DISCOVER-2, significantly greater proportion of patients receiving TREMFYA achieved the primary endpoint, ACR20 response at week 24, compared to patients receiving placebo.⁴^,⁶
The results for changes in FACIT-Fatigue scores through week 52 are summarized in Table: Summary of Least Squares Mean Change from Baseline, Clinically Meaningful Improvement, and Observed Mean Change in FACIT-Fatigue Scores through Week 52.

Summary of Least Squares Mean Change from Baseline, Clinically Meaningful Improvement, and Observed Mean Change in FACIT-Fatigue Scores through Week 52¹

	Least Square Mean Change from Baseline in the FACIT-Fatigue Score
	DISCOVER-1					DISCOVER-2
	TREMFYA		PBO	PBO→TREMFYA		TREMFYA		PBO	PBO→ TREMFYA
	100 mg q8w	100 mg q4w	PBO	PBO→TREMFYA		100 mg q8w	100 mg q4w	PBO	PBO→ TREMFYA
	n=126	n=128	n=126	-		n=247	n=245	n=245	-
Week 8	3.64^d	3.58	2.36	N/A		5.03^a	4.85^a	2.45	N/A
	n=127	n=128	n=125	-		n=248	n=243	n=244	-
Week 16	4.85^b	4.54^c	2.16	N/A		6.98^a	6.60^a	3.70	N/A
	n=127	n=128	n=126	-		n=246	n=245	n=244	-
Week 24	5.61^a	5.84^a	2.21	N/A		7.55^a	7.11^a	3.56	N/A
	n=124	n=128	-	n=123		n=248	n=244	-	n=245
Week 52	6.65	7.08	N/A	5.59		8.30	7.70	N/A	6.87
	Proportion of Patients who Achieved Clinically Meaningful Improvement in the FACIT-Fatigue Score (≥4-Point Change)
	DISCOVER-1					DISCOVER-2
	TREMFYA		PBO (n=126)		PBO→TREMFYA (n=126)	TREMFYA		PBO (n=246)	PBO→ TREMFYA (n=246)
	100 mg q8w (n=127)	100 mg q4w (n=128)	PBO (n=126)		PBO→TREMFYA (n=126)	100 mg q8w (n=248)	100 mg q4w (n=245)	PBO (n=246)	PBO→ TREMFYA (n=246)
Week 8	44.1	43.8	35.7		N/A	56.0^c	51.8	45.9	N/A
Week 16	50.4^b	52.3^b	34.1		N/A	60.9^c	56.7	50.4	N/A
Week 24	53.5^b	63.3^a	34.9		N/A	60.5^a	59.6^b	45.5	N/A
Week 52	55.1	61.7	N/A		52.4	65.7	64.1	N/A	63.8
	Observed Mean Change in the FACIT-Fatigue Score
	DISCOVER-1					DISCOVER-2
	TREMFYA		PBO→TREMFYA			TREMFYA		PBO→TREMFYA
	100 mg q8w	100 mg q4w	PBO→TREMFYA			100 mg q8w	100 mg q4w	PBO→TREMFYA
Week 24	n=123	n=125	n=114			n=238	n=234	n=237
Mean change (SD)	5.9 (10.4)	5.6 (7.8)	2.6 (8.3)			8.0 (9.9)	7.0 (8.6)	3.8 (9.0)
Week 52	n=114	n=124	n=104			n=234	n=229	n=230
Mean change (SD)	7.5 (9.6)	6.9 (8.4)	6.6 (9.4)			8.9 (9.5)	7.7 (9.1)	7.5 (9.4)
Abbreviations: FACIT, Functional Assessment of Chronic Illness Therapy; N/A, not applicable; PBO, placebo; q4w, every 4 weeks; q8w, every 8 weeks; SD, standard deviation. ^aUnadjusted P-value vs placebo P-value<0.001. ^bUnadjusted P-value vs placebo P-value<0.01. ^cUnadjusted P-value vs placebo P-value<0.05. ^dn=126 for the TREMFYA 100 mg q8w.

In the DISCOVER-2 post hoc analysis, among TREMFYA-treated patients, an improvement in the FACIT-Fatigue score of ≥2 points between baseline and week 8 was identified as the optimal cut-off predicting clinically meaningful improvement (≥4-point change) at week 100.²
- The results for changes in FACIT-Fatigue scores between weeks 52 and 100 are summarized in Table: Summary of Least Squares Mean Change from Baseline, Clinically Meaningful Improvement, and Normative FACIT-Fatigue Scores Between Weeks 52 and 100 in DISCOVER-2.²

Summary of Least Squares Mean Change from Baseline, Clinically Meaningful Improvement, and Normative FACIT-Fatigue Scores Between Weeks 52 and 100 in DISCOVER-2²

	Least Square Mean Change from Baseline in the FACIT-Fatigue Score^a
	TREMFYA 100 mg q8w (n=231)	TREMFYA 100 mg q4w (n=217)	Pooled TREMFYA (n=681)	PBO→TREMFYA q4w (n=233)
Week 52	9.20	8.94	8.63	7.79
Week 76	9.87	9.76	9.56	9.07
Week 100	10.33	10.31	10.04	9.52
P-value^b	0.02	0.006	<0.0001	0.0003
	Proportion of Patients who Achieved Clinically Meaningful Improvement in the FACIT-Fatigue Score (≥4-Point Change)
	TREMFYA 100 mg q8w (n=231)	TREMFYA 100 mg q4w (n=217)	Pooled TREMFYA (n=681)	PBO→TREMFYA q4w (n=233)
Week 52	68.0	69.6	67.8	66.1
Week 76	66.2	72.4	68.1	66.1
Week 100	68.4	71.4	68.4	65.7
	Proportion of Patients who Achieved Normative FACIT-Fatigue (FACIT-Fatigue Score >43)
	TREMFYA 100 mg q8w (n=231)	TREMFYA 100 mg q4w (n=217)	Pooled TREMFYA (n=681)	PBO→TREMFYA q4w (n=233)
Week 52	29.4	28.1	27.5	24.9
Week 76	33.8	30.9	31.0	28.3
Week 100	34.6	33.6	32.0	27.9
P-value^b	-	-	0.0095	-
Note: The proportion of patients with clinically meaningful improvement (≥4-point change) from baseline in the FACIT-Fatigue score and with normative FACIT-Fatigue levels between weeks 52 and 100 was calculated using NRI for missing data and compared over time within each treatment group using the McNemar χ² test. Abbreviations: FACIT, Functional Assessment of Chronic Illness Therapy; NRI, nonresponder imputation; PBO, placebo; q4w, every 4 weeks; q8w, every 8 weeks. ^aLeast square mean change from baseline in the FACIT-Fatigue score adjusted for visit, treatment group, interaction of visit with treatment group, and baseline FACIT-Fatigue score. ^bvs week 52. The endpoint was not controlled for multiple comparisons. Therefore, the P-values displayed are nominal, and statistical significance has not been established.

In both DISCOVER-1 and DISCOVER-2, mediation analysis of changes from baseline in the FACIT-Fatigue score after 24 weeks showed that of the total treatment effect, there was a direct effect on fatigue in the TREMFYA 100 mg q8w group (11.7% in DISCOVER-1 and 36.3% in DISCOVER-2) and in the TREMFYA 100 mg q4w group (68.5% in DISCOVER-1 and 69.7% in DISCOVER-2). These changes were independent of those mediated by the achievement of ACR20 response.
Results of mediation analyses also indicated that improvements in the FACIT-Fatigue scores at week 24 were partially mediated by ACR20 response. Adjusting for clinical outcomes, including change in CRP concentration at week 24 from baseline and achievement of minimal disease activity, showed similar independent treatment effects of TREMFYA on FACIT-Fatigue scores (Table: Mediation Analysis of the Effects of Improvements in Clinical Responses on the Reduction in Fatigue Associated with TREMFYA Treatment).

Mediation Analysis of the Effects of Improvements in Clinical Responses on the Reduction in Fatigue Associated with TREMFYA Treatment¹

Effect	DISCOVER-1		DISCOVER-2
	TREMFYA		TREMFYA
	100 mg q8w vs Placebo	100 mg q4w vs Placebo	100 mg q8w vs Placebo	100 mg q4w vs Placebo
ACR20 response
Total effect (95% CI)	3.12 (1.05-5.15)^a	3.79 (1.94-5.44)^a	3.97 (2.41-5.53)^a	3.58 (2.10-5.05)^a
Direct effect, %	11.7	68.5	36.3	69.7
Indirect (mediated) effect, %	88.3	31.5	63.7	30.3
CRP (change from baseline)
Total effect (95% CI)	3.06 (0.95-5.17)^a	3.61 (1.74-5.47)^a	3.80 (2.24-5.36)^a	3.37 (1.93-4.81)^a
Direct effect, %	81.8	88.4	84.3	85.5
Indirect (mediated) effect, %	18.2	11.6	15.7	14.5
MDA
Total effect (95% CI)	3.08 (0.99-5.18)^a	3.62 (1.76-5.49)^a	3.74 (2.13-5.34)^a	3.41 (1.96-4.86)^a
Direct effect, %	76.0	78.4	71.5	91.7
Indirect (mediated) effect, %	24.0	21.6	28.5	8.3
Abbreviations: ACR20, ≥20% improvement in the American College of Rheumatology composite measures of arthritis; CI, confidence interval; CRP, C-reactive protein; MDA, minimal disease activity; q4w, every 4 weeks; q8w, every 8 weeks. The mediation analysis used ACR20 and MDA as dichotomous mediators and change in CRP as a continuous mediator. ^aP-value vs placebo: <0.05.

Coates et al (2022)³ evaluated the efficacy and safety of TREMFYA in adult patients with active PsA who demonstrated inadequate response to 1-2 TNFi in a randomized, double-blind, placebo-controlled, multicenter, phase 3b study (COSMOS).

Study Design/Methods

Select inclusion criteria: patients ≥18 years of age, active PsA for ≥6 months, ≥3 swollen joints and ≥3 tender joints for ≥6 months, patients who met the Classification Criteria for Psoriatic Arthritis criteria at screening, active (≥1 psoriatic plaque of ≥2 cm) or documented history of plaque psoriasis or current nail psoriasis, inadequate response or intolerance to 1-2 TNFi.³^,⁸
Patients were randomized in a 2:1 ratio to receive either TREMFYA 100 mg or placebo subcutaneously at weeks 0, 4, and q8w thereafter through week 44.
The study comprised of placebo-controlled (weeks 0-24) and active-treatment (weeks 24-48) periods, with final study intervention at week 44.
At week 24, all remaining randomized placebo patients crossed over to receive TREMFYA 100 mg at weeks 24, 28, and q8w thereafter through week 44.
The primary endpoint was an ACR20 response at week 24.
The proportion of patients with an increase in the FACIT-Fatigue score of at least 4 points from baseline (clinically meaningful improvement) was assessed as a secondary endpoint.³

Results

Patient Characteristics

Overall, 285 patients were randomized to receive TREMFYA 100 mg (n=189) or placebo (n=96).
Baseline demographics are summarized in Table: Summary of Patient Baseline Demographics.

Summary of Patient Baseline Demographics³

	Placebo n=96	TREMFYA 100 mg n=189
Mean age, years	49	49
Sex, female, %	46	54
Psoriatic arthritis duration, years, mean	8.7	8.3
BMI, kg/m², mean	31^a	29
Number of swollen joints (0-66), mean	9	10
Number of tender joints (0-68), mean	18	21
Patient’s assessment of pain, 0-10 cm VAS, mean	6.0	6.5
Patient’s global assessment of arthritis, 0-10 cm VAS, mean	6.2	6.5
Physician’s global assessment of disease, 0-10 cm VAS, mean	6.4	6.9
CRP, mg/dL, mean	1.2	1.2^b
FACIT-Fatigue score, 0-52, mean	29.2	29.2^b
Number of prior TNFi, %
1	89	88
2	11	12
Reason for prior TNFi discontinuation, %
Inadequate response	82	84
Intolerance	18	16
Abbreviations: BMI, body mass index; CRP, C-reactive protein; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; TNFi, tumor necrosis factor inhibitor; VAS, visual analogue scale. ^an=95. ^bn=188.

Efficacy

At week 24, the primary endpoint for ACR20 response rates in the TREMFYA group was 44.4% (84/189) vs 19.8% (19/96) of placebo-treated patients (P<0.001).
Higher proportion of patients in the TREMFYA 100 mg vs placebo group achieved clinically meaningful improvement in the FACIT-Fatigue score; see Table: FACIT-Fatigue Response at Weeks 24 and 48.

FACIT-Fatigue Response at Weeks 24 and 48³

	Week 24			Week 48
	Placebo n=96	TREMFYA 100 mg n=189	% Difference (95% CI)	Placebo→ TREMFYA 100 mg n=51^a	TREMFYA 100 mg n=189
FACIT-Fatigue response (≥4-point improvement from baseline), n (%)	20 (20.8)	81^a (42.9)	21.9 (11.2-32.7)	26 (51.0)	105 (55.6)
Abbreviations: CI, confidence interval; csDMARD, conventional synthetic diseasemodifying antirheumatic drug; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; TNFi, tumor necrosis factor inhibitor. ^aNominal P-value <0.001 for placebo vs TREMFYA 100 mg, stratified by the baseline use of csDMARD (yes/no) and prior exposure to TNFi (1 vs 2). The endpoint was not controlled for multiple comparisons. Therefore, the P-value is nominal, and statistical significance has not been established.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 10 July 2024.

References

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1	Rahman P, Mease P, Helliwell P, et al. Guselkumab demonstrated an independent treatment effect in reducing fatigue after adjustment for clinical response—results from two phase 3 clinical trials of 1120 patients with active psoriatic arthritis. Arthritis Res Ther. 2021;23(1):190.
2	Gladman D, Starr M, Ranza R, et al. Long-term efficacy of guselkumab in fatigue and identification of early treatment targets: post-hoc analysis through 2 years of a phase 3, randomized, double-blind, placebo-controlled study conducted in biologic-naïve patients with active psoriatic arthritis. Poster presented at: American College of Rheumatology Convergence; November 10-14, 2022; Philadelphia, PA.
3	Coates L, Gossec L, Theander E, et al. Supplement to: Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS). Ann Rheum Dis. 2022;81(3):359-369.
4	Deodhar A, Helliwell P, Boehncke W, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFα inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1115-1125.
5	Deodhar A, Helliwell P, Boehncke W, et al. Supplement to: Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNF,α inhibitor treatment (DISCOVER-1):a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1115-1125.
6	Mease PJ, Rahman P, Gottlieb AB, et al. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126-1136.
7	Mease P, Rahman P, Gottlieb A, et al. Supplement to: Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020;395(10230):1126-1136.
8	Coates L, Gossec L, Theander E, et al. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who demonstrated inadequate response to tumor necrosis factor inhibition: results of a phase 3b, randomized, controlled study. Oral presentation presented at: EULAR Congress; June 2-5, 2021; Virtual.